ISPE Hands-on Training: Impact of the Annex 1 Revisions
In Person, Deep Dive Training
Driven primarily by biopharmaceuticals but also important in small molecule drug product manufacturing and APIs, aseptic processing is undergoing a technology transformation driven by the new EC GMP Guide Annex 1. Companies globally that deliver medicinal products to Europe must comply with the new regulatory requirements. The Annex 1 revisions impact not only product manufacturers, but also engineering firms and equipment suppliers when providing services or equipment in either renovated or new production facilities.
The requirements of the new Annex 1 must be implemented in the production of sterile and aseptic processes. The industry is currently within the 1-year implementation period, and after the 24th of August 2023 manufacturers must fulfill the new Annex 1 requirements.
ISPE is offering a training program centered on how to implement these new requirements with a best practices approach. This training encompasses the two main pillars of the Annex 1: Quality Risk Management (QRM) and Contamination Control Strategy. In addition, this program covers aseptic production operations from compounding to fill & finish and freeze drying. The program consists of 2 full days at the Europe Aseptic and Sterile Environment (EASE) Training Center in Strasbourg, France. The EASE Training Center provides Hands-on opportunities to interact with facilities, equipment, and staff members in an industrial environment specifically built for training pharmaceutical industry workers.
Visit EASE Training Center Industrial Platform for the Pharmaceutical Manufacturing (ease-training.fr) to learn how ISPE training courses coupled with hands-on activities at the EASE Training Center will benefit you in this interactive program. ISPE instructors are excited to welcome you to this training event in Strasbourg.
What to Expect?
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Production & QC area upstream
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Production & QC area upstream 2
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Production area for sterile liquids
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Production area for dry forms
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Air treatment system
Hands-On Aseptic Processing & Annex 1 Training
21 - 22 Jun 2023
The program consists of 2 full days at the Europe Aseptic and Sterile Environment (EASE) Training Center in Strasbourg, France. The EASE Training Center provides Hands-on opportunities to interact with facilities, equipment, and staff members in an industrial environment specifically built for training pharmaceutical industry workers. For this session, ISPE will conduct focused training on Aseptic Processing & Annex 1. Aseptic Processing & Annex 1 trainees will have the opportunity to enter graded clean rooms and interact with the single-use equipment as well as stainless steel equipment. Trainees will participate in fill & finish production under the direction of the EASE facility leaders. In addition, trainees will have the opportunity to discuss advantages/disadvantages in practice for all these elements and assess the impact on facilities design.
Upon completion of this course, trainees will be able to:
- Understand the new EC GMP Guide Annex 1 and its impact on future aseptic processing
- Determine the current industry standards for manufacturing and environmental control
- Engage in critical topics discussion in regulators inspections
Jean Francois Duliere is a Pharmacist by education. Jean Francois started his professional life 20 years in pharmaceutical industry Quality Control, Production in various positions and various fields, OSD, Steriles, API from Bacteria growth. Jean Francois joined after this production experience an Engineering company Technip where he stayed for 20 years doing facilities design for OSD; Sterile, Biotech, Vaccines, Advanced Therapy Medicines facilities. In charge of early design stages and GMP compliance of most of Technip's pharma projects. Jean Francois is involved in many ISPE working groups and committees.
Jörg Zimmermann is currently Vice President External Affairs for Vetter Pharma Fertigung GmbH&Co KG, Ravensburg, Germany. In this role, he manages the relationships with regulatory agencies, professional organizations and other partners in the pharmaceutical industry. Before taking this role, he was responsible for Vetter Development Service which includes manufacturing science & process development, technology & process transfers, project & service analytics and drug delivery systems. Within Vetter, Jörg has held various positions in process implementation, new product introduction, lyophilization process development and as production manager before becoming Director of Production of Vetter's production site at Lake Constance in 2000. There he managed 5 production lines for aseptically prefilled injection systems. In September 2010 he became responsible for the process development and process introduction group at Vetter before being promoted to Vice President in November 2014.